Bone repair system, kit and method

ABSTRACT

A bone repair system, kit and method for percutaneous repair of a bone segment containing a first bone segment and a second bone segment in a patient, each bone segment having a drill hole. The system comprises a longitudinal member configured to contact the first bone segment and the second bone segment and having at least one opening and cleats on the side adapted to contact the first bone segment and the second bone segment; a first fastener assembly configured to be disposed through the opening of the longitudinal member to hold the longitudinal member in place through the opening and the hole in the first bone segment; and a second fastener assembly configured to be disposed through the opening of the longitudinal member to hold the longitudinal member in place through the opening and the hole in the second bone segment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application does not claim the benefit of any other application.

TECHNICAL FIELD

This invention relates to a system, kit and method for the repair offractured or broken bones, such as ribs.

BACKGROUND

Chest wall fractures, and in particular, fractures of rib bones of therib cage, can cause potentially life-threatening respiratoryinsufficiencies, accounting for up to 50% of the mortality in thoraxinjuries. Fracture of a rib bone can occur at any location along thebone. Most rib fractures are treated conservatively using painmanagement and/or bracing techniques, but often the pain experienced bythe patient during healing can be severe and last for one to two months.In addition, fractured ribs in a flail chest, a condition that occurswhen a minimum of three adjacent ribs are broken, treated in such amanner may undergo progressive displacement during the healing phase,resulting in considerable deformity, volume loss, atelectasis, andchronic pain. Long-term problems of patients with flail chest injuriestreated nonoperatively include subjective chest tightness, thoracic cagepain, and dyspnea.

Four categories of fixation devices for operative chest wall fixationhave been utilized, namely plates, intramedullary devices, verticalbridging, and wiring. The results of these repair techniques are oftenless than desirable because of the difficulty in correctly locating thebroken rib ends with one another. Stabilizing rib fractures ischallenging because large incisions are typically needed to accommodatefixation, which leads to a more morbid procedure. In addition, ribs arenarrow with a thin cortex that surrounds soft marrow, making reliablefixation problematic under conditions that include upwards of 25,000breathing cycles per day, as well as coughing.

Currently, the surgery involves a significant operative procedure withmobilization of fractured ribs or open thoracotomy. The problems andrisks of an operative approach include the surgical trauma itself andthe loosening and migration of implants. The surgery involves a majorincision through the muscle directly down to the ribs, which can havecomplications such as loss of muscle function, blood loss, and damage tosurrounding vascular and neural tissue. The ribs that are to be fixedneed to be adequately exposed in order to obtain a good placement ofmetal fixation plates. A wide incision is performed, and myocutaneousflaps may need to be raised to allow visualization of all segments.Posterior injuries are usually challenging due to the presence andrequired exposure of large muscle fibers (e.g., latissimus dorsi,trapezius, rhomboids, paraspinous muscles).

United States Patent Application 2010/0331892 to Fell et al, thedisclosure of which is incorporated herein by reference, represents animprovement over the above-described prior art. However, the system, kitand method of the invention described in the instant specificationrepresents a significant improvement over the teaching of Fell et al.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a bone repair system in accordance with anaspect of an illustrative embodiment.

FIG. 2 is a top perspective of a bone repair system in accordance withan aspect of an illustrative embodiment.

FIG. 3 is a top view of a bone repair system in accordance with anaspect of an illustrative embodiment.

FIG. 4 is a bottom perspective view of a bone repair system inaccordance with an aspect of an illustrative embodiment.

FIG. 5 is a bottom view of a bone repair system in accordance with anaspect of an illustrative embodiment.

FIG. 6 is a top perspective view of a longitudinal member in accordancewith an aspect of an illustrative embodiment.

FIG. 7 is a top view of a longitudinal member in accordance with anaspect of an illustrative embodiment.

FIG. 8 is a bottom view of a longitudinal member in accordance with anaspect of an illustrative embodiment.

FIG. 9 is a perspective view of a pivoting locking post in accordancewith an aspect of an illustrative embodiment.

FIG. 10 is a bottom view of a pivoting locking post in accordance withan aspect of an illustrative embodiment.

FIG. 11 is a top view of a pivoting locking post in accordance with anaspect of an illustrative embodiment.

FIG. 12 is a side view of a pivoting locking post in accordance with anaspect of an illustrative embodiment.

FIG. 13 is a perspective view of a locking cap in accordance with anaspect of an illustrative embodiment.

FIG. 14 is a side view of a locking cap in accordance with an aspect ofan illustrative embodiment.

FIG. 15 is a top view of a locking cap in accordance with an aspect ofan illustrative embodiment.

FIG. 16 is a bottom view of a locking cap in accordance with an aspectof an illustrative embodiment.

FIG. 17 is a perspective view of a positioning forceps in accordancewith an aspect of an illustrative embodiment.

FIG. 18 is a front view of a positioning forceps in accordance with anaspect of an illustrative embodiment.

FIG. 19 is a side view of a positioning forceps in accordance with anaspect of an illustrative embodiment.

FIG. 20 is a rear view of a positioning forceps in accordance with anaspect of an illustrative embodiment.

FIG. 21 is a top view of a positioning forceps in accordance with anaspect of an illustrative embodiment.

FIG. 22 is a perspective view of a positioning forceps in an openposition in accordance with an aspect of an illustrative embodiment.

FIG. 23 is a perspective view of a drill bit guide in accordance with anaspect of an illustrative embodiment.

FIG. 24 is a perspective view of a drill bit in accordance with anaspect of an illustrative embodiment.

FIG. 25 is a perspective view of a drill bit inserted in a drill bitguide in accordance with an aspect of an illustrative embodiment.

FIG. 26. is a front view of a positioning forceps with a drill bit guidecontacting a bone segment in accordance with an aspect of anillustrative embodiment.

FIG. 27 is a side view of an external drive tool in accordance with anaspect of an illustrative embodiment.

FIG. 28 is a side cut-away view of an external drive tool self-retaininghex drive in accordance with an aspect of an illustrative embodiment.

FIG. 29 is a bottom view of an external drive tool in accordance with anaspect of an illustrative embodiment.

FIG. 30 is an illustration of a patient with broken ribs.

FIG. 31 is an illustration of an incision and ports in accordance withan aspect of an illustrative embodiment.

FIG. 32 is an illustration of an incision template placed over apatient's broken ribs in accordance with an aspect of an illustrativeembodiment.

FIG. 33 is an illustration of the positioning forceps about to beinserted into incisions over the patient's broken ribs in accordancewith an aspect of an illustrative embodiment.

FIG. 34 is an illustration of the positioning forceps contacting bonesegments in the patient's broken ribs in accordance with an aspect of anillustrative embodiment.

FIG. 35 is an illustration of the positioning forceps of FIG. 34 withdrill bit guides inserted into the forceps in accordance with an aspectof an illustrative embodiment.

FIG. 36 is a perspective view of a drill bit with indicators forindicating the depth of a hole made by the drill bit along with lockingcaps configured to be used in drill holes of varying depth in accordancewith an aspect of an illustrative embodiment.

FIG. 37 is an illustration of guide tubes being inserted into the drillbit guides in accordance with an aspect of an illustrative embodiment.

FIG. 38 is an illustration of guide tubes being inserted through holesin the bone segments of the patient's broken ribs in accordance with anaspect of an illustrative embodiment.

FIG. 39 is an illustration of the ends of the guide tubes being removedfrom an incision away from the patient's ribs in accordance with anaspect of an illustrative embodiment.

FIG. 40 is an illustration showing the guide tubes after the ends of theguide tubes have been removed from an incision away from the patient'sribs in accordance with an aspect of an illustrative embodiment.

FIG. 41 is an illustration of a tether inserted through the pivotinglocking posts of the longitudinal member being inserted into the guidetubes in accordance with an aspect of an illustrative embodiment.

FIG. 42 is an illustration of the ends of the tether being removed fromthe ends of the guide tubes opposite to the ends in which the tetherswere inserted in accordance with an aspect of an illustrativeembodiment.

FIG. 43 is an illustration showing the tethers remaining in thepatient's body after the guide tubes have been removed in accordancewith an aspect of an illustrative embodiment.

FIG. 44 is an illustration showing the longitudinal member being pulledinto the patient's body.

FIG. 45 is a close up view of the longitudinal member with the pivotinglocking posts collapsed in the member in accordance with an aspect of anillustrative embodiment.

FIG. 46 is a close up view of the longitudinal member with the pivotinglocking posts in an upright position in accordance with an aspect of anillustrative embodiment.

FIG. 47 is an illustration of the longitudinal member about to beinserted into holes in the patient's ribs in accordance with an aspectof an illustrative embodiment.

FIG. 48 is an illustration of an external drive tool with the tethersinserted in a longitudinal cavity in the hex drive in accordance with anaspect of an illustrative embodiment.

FIG. 49 is an illustration of an external drive tool engaging a lockingcap in the bone repair system in an aspect of an illustrativeembodiment.

FIGS. 50 A, B, and C show the locking cap and the pivoting locking postin varying degrees of engagement in accordance with an aspect of anillustrative embodiment.

FIG. 51 shows an illustration of the external drive tool being removedfrom the body in accordance with an aspect of an illustrativeembodiment.

FIG. 52 shows the patient's broken ribs joined by the bone repair systemin an aspect of an illustrative embodiment in accordance with an aspectof an illustrative embodiment.

FIG. 53 shows a removal driver being inserted over tethers prior toremoval of the bone repair system in an aspect of an illustrativeembodiment in accordance with an aspect of an illustrative embodiment.

SUMMARY

An improved bone repair system, kit and method are described herein. Inone aspect, a system for the percutaneous repair of a first bone segmentand a second bone segment of a fractured bone having a drill hole ineach bone segment in a patient is shown comprising: a longitudinalmember configured to contact the first bone segment and the second bonesegment and having at least one opening and cleats on the side adaptedto contact the first bone segment and the second bone segment; a firstfastener assembly configured to be disposed through the opening of thelongitudinal member to hold the longitudinal member in place through theopening and the hole in the first bone segment; and a second fastenerassembly configured to be disposed through the opening of thelongitudinal member to hold the longitudinal member in place through theopening and the hole in the second bone segment. In a preferredembodiment, the first bone segment and the second bone segment are ribbone segments.

In another aspect, the longitudinal member contains a first opening anda second opening and the first fastener assembly is configured to bedisposed through the first opening of the longitudinal member to holdthe longitudinal member in place through the first opening and the holein the first bone segment; and wherein the second fastener assembly isconfigured to be disposed through the second opening of the longitudinalmember to hold the longitudinal member in place through the secondopening and the hole in the second bone segment.

In a preferred embodiment, the hole in the first bone segment and thehole in the second bone segment are generally centered over the width ofthe respective bone segment.

In another preferred embodiment, the first fastener assembly includes afirst inner fastener and a first outer fastener, and the second fastenerassembly includes a second inner fastener and a second outer fastener.In an even more preferred embodiment, the first outer fastener and thesecond outer fastener are selected based upon the thickness of the firstbone segment and the second bone segment respectively.

In another preferred embodiment, the longitudinal member is flexiblesuch that the stiffness of the longitudinal member is similar to thestiffness of the bone segment to which it is attached. Use of a flexiblelongitudinal member promotes bone healing and avoids unintendedfractures and pain to the patient. In still another preferredembodiment, the cleats on the longitudinal member are shaped so as todig into the first bone segment and the second bone segment when thelongitudinal member is contacted with the first bone segment and thesecond bone segment. The cleats may be of a variety of shapes includingpyramidal and trapezoidal.

In a preferred embodiment, the first outer fastener is a locking cap andthe second outer fastener is a locking cap. In another preferredembodiment, the first inner fastener is a pivoting locking post and thesecond inner fastener is a pivoting locking post, wherein thelongitudinal member has slots adapted to receive the pivoting lockingposts. The locking posts can pivot between a collapsed position and anextended position.

In another preferred embodiment, the first outer fastener is a lockingcap shaped so as to be turnable by an external drive and the secondouter fastener is a locking cap shaped so as to be turnable an externaldrive.

In another preferred embodiment, either the locking caps or the pivotinglocking posts have lobed locking threads.

In another preferred embodiment, the locking caps have cutouts spacedaround the cap so as to grip and dig into the outer cortex of a bonesegment when contacted against a bone segment and wherein the cutoutsare of sufficient depth to restrain the caps from being overtightened.In still another preferred embodiment, the portion of the locking capsthat has cutouts is rounded in shape and has at least one external drivefeature. A locking cap with between one and eight drive features ispreferred. More preferably, there are four drive features. Alsopreferred are six drive features.

In a preferred embodiment for engaging the external drive features ofthe locking cap, an external drive tool is used. A preferred embodimentof the external drive tool is a self-retaining hex drive.

In another aspect, a kit for surgical repair of a fractured boneinvolving a first bone segment and a second bone segment is disclosedcomprising: a first tether and a second tether each having a proximalend and a distal end configured to be inserted into a first guide tubeand a second guide tube respectively; a longitudinal member having atleast one opening configured to receive a first fastener assembly and asecond fastener assembly wherein the longitudinal member is configuredto be in contact with the first and second bone segments and has cleatson the side configured to be in contact with the first and second bonesegments; a first fastener assembly having a longitudinal channelconfigured for passing the first tether therethrough and furtherconfigured to hold the longitudinal member against the first bonesegment; and a second fastener assembly having a longitudinal channelconfigured for passing the second tether therethrough and furtherconfigured to hold the longitudinal member against the second bonesegment.

In a preferred embodiment, the longitudinal member has a first openingconfigured to receive the first fastener assembly and a second openingconfigured to receive the second fastener assembly.

In a preferred embodiment, the kit further comprises a first guide tubeand a second guide tube. In still another preferred embodiment, the kitfurther comprises an incision template.

In another preferred embodiment, the kit further comprises a positioningforceps configured to engage a bone segment and a drill guide configuredto be received through the positioning forceps for facilitating drillinga hole in a bone segment.

In another preferred embodiment, the kit further comprises furthercomprises a drive tool having a longitudinal channel configured to passa tether therethrough.

In another preferred embodiment, the first fastener assembly comprisesan inner and outer fastener and the second fastener assembly comprisesan inner and an outer fastener. In another preferred embodiment, the kitcontains a plurality of outer fasteners configured to fit in bonesegments of various thicknesses.

In another preferred embodiment, the first outer fastener is a lockingcap and the second outer fastener is a locking cap. Also preferred is anembodiment where the first inner fastener is a pivoting locking post andthe second inner fastener is a pivoting locking post, and wherein thelongitudinal member has slots adapted to receive the pivoting lockingposts.

In another preferred embodiment, the cleats on the longitudinal memberare shaped so as to dig into the first bone segment and the second bonesegment when the longitudinal member is contacted with the first bonesegment and the second bone segment.

In still another preferred embodiment, the kit further comprises aremoval driver.

In yet another preferred embodiment, the kit further comprises packagingcontaining the kit components. The kit may comprise packaging containingthe longitudinal member, the first tether, the second tether, the firstfastener assembly, and the second fastener assembly and wherein thelongitudinal member, the first tether, the second tether, the firstfastener assembly and the second fastener assembly have been sterilized.

In another aspect, a method of percutaneously fixing a first bonesegment to a second bone segment in a body of a patient is disclosedcomprising drilling a first hole through the first bone segment and asecond hole through the second bone segment; feeding a first guide tubethrough the first hole and a second guide tube through the second hole,each guide tube having a proximal end and a distal end; withdrawing thefirst and second guide tube distal ends from the body while the firstand second guide tube proximal ends have not passed through the firstand second bone segments respectively; feeding a first tether throughthe first guide tube and a second tether through the second guide tube,each tether having a proximal end and a distal end; withdrawing thefirst and second tether distal ends from the body while the first andsecond tether proximal ends have not passed through the first and secondbone segments respectively; removing the guide tubes from the body whilekeeping the first and second tethers in the body; passing a longitudinalmember having at least one opening and cleats on the side contacting thefirst bone segment and the second bone segment onto the first and secondtether ends; pulling the longitudinal member into engagement with thefirst and second bone segments guided by the tethers; and securing thelongitudinal member to the first bone segment with a first fastenerassembly through the first hole and the opening in the longitudinalmember and to the second bone segment with a second fastener assemblythrough the second hole and the opening in the longitudinal member tofix the first bone segment to the second bone segment.

In another preferred embodiment, the longitudinal member comprises afirst opening and a second opening, and wherein the step of passing thelongitudinal member onto the first and second tether ends comprisespassing the first tether end through the first opening and the secondtether end through the second opening.

In a preferred embodiment of the method, the first bone segment and thesecond bone segment are rib bone segments.

In another preferred embodiment of the method, the method furthercomprises making a percutaneous incision above the first bone segmentand the second bone segment. Thus, a person of ordinary skill wouldunderstand that a single incision could be used instead of two separateincisions. This includes making one incision and mobilizing soft tissueto drill a hole over a separate location. Alternatively, the method mayalso comprise making a first percutaneous incision above the first bonesegment and a second percutaneous incision above the second bone segmentwherein an incision template is used to align the location of the firstand second percutaneous incisions. The incision template is an optionalbut advantageous feature of the method.

In still another preferred embodiment, the method comprises making athird percutaneous incision for withdrawing the distal ends of the guidetubes from the body. Instead of a percutaneous incision, the method maycomprise making a port for withdrawing the distal ends of the guidetubes from the body.

In yet another preferred method, the method further comprises using afirst positioning forceps containing a drill bit guide to align a drillover the first bone segment and a second positioning forceps containinga drill bit guide to align a drill over the second bone segment. Itshould be understood that first forceps and the second forceps may bethe same. That is, a surgeon could use a forceps on one bone segment andthen switch the forceps to the other bone segment.

In another preferred method, the method comprises using the first andsecond positioning forceps to align the drill such that each hole isgenerally centered over the width of the bone segment.

The method may involve preferred structures used in the above-describedsystem. Thus, the method may involve a first fastener assembly thatincludes a first inner fastener and a first outer fastener, and a secondfastener assembly that includes a second inner fastener and a secondouter fastener. In a preferred embodiment, the method comprises the stepof selecting the first outer fastener and the second outer fastenerbased upon the thickness of the first bone segment and the second bonesegment respectively.

In another preferred embodiment of the method, the first outer fasteneris a locking cap and the second outer fastener is a locking cap. In yetanother preferred embodiment of the method, the first inner fastener isa pivoting locking post and the second inner fastener is a pivotinglocking post, wherein the longitudinal member has slots adapted toreceive the pivoting locking posts.

In another preferred embodiment, the method further comprises the stepof pulling the longitudinal member into the body towards the first andsecond bone segments wherein the pivoting locking posts are collapsedinto the reinforcing member as the reinforcing member moves through thebody towards the first and second bone segments.

In another preferred embodiment, the first outer fastener is a lockingcap shaped so as to be turnable by an external drive and the secondouter faster is a locking cap shaped so as to be turnable by an externaldrive. In still another preferred embodiment, the method furthercomprises the step of tightening the first and second outer fastenerswith an external drive wherein the external drive has a longitudinalchannel for passing a tether therethrough.

In yet another preferred embodiment of the method, either the lockingcaps or the pivoting lock posts have lobed locking threads. In anotherpreferred embodiment, the method further comprises the step of lockingthe locking cap and the pivoting locking post via the lobed lockingthreads.

In another preferred embodiment of the method, the locking cap hascutouts spaced around the cap so as to grip and dig into the outercortex of a bone segment and wherein the cutouts are of sufficient depthto resist the cap from being overtightened.

In another preferred embodiment of the method, the longitudinal memberhas been preassembled such that first and second tethers passtherethrough prior to feeding the first and second tethers into theguide tubes. Thus, it should be understood by those of skill in the artthat this would encompass pre-assembly of the longitudinal member/tethercombination by a manufacturer so that a surgeon need not prepare theassembly prior to or during surgery. However, it would also encompasspre-assembly by the surgeon or other healthcare facility staff.

In another preferred embodiment of the method, the method furthercomprises tightening the first fastener assembly and the second fastenerassembly so that the cleats on the longitudinal member dig into thefirst bone segment and the second bone segment.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

As required, detailed illustrative embodiments are disclosed herein;however, it is to be understood that the disclosed embodiments aremerely exemplary of the invention that may be embodied in various andalternative forms. The figures are not necessarily to scale; somefeatures may be exaggerated or minimized to show details of particularcomponents. Therefore, specific structural and functional detailsdisclosed herein are not to be interpreted as limiting, but merely as arepresentative basis for teaching one skilled in the art to variouslyemploy the illustrative embodiments disclosed herein.

Disclosed herein is a system, kit and method for repairing fractured orbroken bones, such as ribs. The system, kit and method according to thepresent invention allow bone repair to be performed in a minimallyinvasive manner, thereby lessening patient recovery time. Although thesystem, kit and method are shown and described herein as being appliedto the repair of fractured ribs, it is understood that their applicationto the repair of other broken bones is fully contemplated. For example,the system and method according to the present invention may also beutilized for the minimally invasive repair of bone segments such as afractured clavicle, fractured tibia, fractured pelvis, fractured spine,or fractured joint surface where there are displaced and/or multiplebone fragments that would otherwise require a large open surgicalexposure to repair.

In overview, in accordance with an aspect of the illustrativeembodiments, fixation of bone segments such as fractured ribs includesthe placement of tethered repair components through a percutaneous skinincision down to the bone and delivery of repair components into thepleural space. Assistance may be provided by a video-thorascope, imagingtechnologies, or other minimally invasive observation method. Thetethered repair components include a longitudinal member with cleats onthe side configured to contact the bone, such as a bone plate, and afastener assembly, such as a locking cap and pivoting locking post orother compressive fastener assembly, wherein the broken rib segment isstabilized by securing the longitudinal member against the rib with thefastener assembly. The longitudinal member may be attached to the rib onits internal surface, the side of the rib lining the pleural space. Thetether, such as a cable, cord, or rod, serves to facilitate theprocedure by guiding and providing control over the repair components,and to provide safety and efficiency for the surgeon.

The use of such a system of rib fixation according to the one aspect ofan illustrative embodiment allows for the passage of fastener hardwarethrough the central, thickest portion of the rib, thus reducing the riskof inadvertent damage to the peripheral neurovascular anatomy. Further,the rib is a very small bone that typically has only a thin corticalshell or, in some cases, is comprised of largely cartilaginous material.Thus, a traditional repair utilizing typical bone screws has a chance ofthe screw loosening over time.

A rib fracture repair can be performed in accordance with an aspect ofan illustrative embodiment utilizing one or more small percutaneousincisions. One or more incisions may be utilized to percutaneouslylocate and drill holes for the passage of fasteners which allow forsimultaneous capture and engagement with both inner and outer portionsof the rib and mechanical interlock with the longitudinal member.Another incision or port allows for the percutaneous insertion offasteners and reinforcing members to be placed against the rib via thepleural space. A still further incision or port may be utilized to allowfor thorascopic visualization of the fracture site. In the drawingsprovided herein, although not shown, it is understood that the patient'sskin overlies the ribs and the above-described incisions are madetherethrough.

With reference to FIGS. 1 to 5, a system for bone repair 1 in accordancewith an aspect of the present invention is shown. System 1 contacts afirst bone segment 3 in rib 2 to a second bone segment 3′ in rib 2. Thebone 2 has a fracture 10. System 1 contacts the bone segments 3, 3′ inrib 2 using longitudinal member 4. Longitudinal member 4 can take avariety of shapes and has cleats 5 on the side of the member contactingthe bone. Longitudinal member 4 is held in place by first fastenerassembly 6 and second fastener assembly 7. The first and second fastenerassemblies preferably comprise an inner fastener 8 and an outer fastener9. In a preferred embodiment, inner fastener 8 is a pivoting lockingpost and outer fastener 9 is a locking cap. It should be understood thatthe fasteners could be reversed so that the outer fastener would beswitched with the inner fastener and vice versa.

Turning to FIGS. 6 to 8, an exemplary longitudinal member 4 is shown inmore detail. Longitudinal member 4 is configured to be contacted withbone segments in a broken bone (not shown). Longitudinal member 4 hascleats 5 on the side configured to be contacted with the bone segments.Longitudinal member 4 further comprises a first opening 11 and a secondopening 12 for passing first and second inner fasteners (not shown)through to hold longitudinal member 4 against the bone segments. In apreferred embodiment, longitudinal member 4 has slots 14 in openings 11and 12 to permit insertion of a pivoting locking post (not shown).

Cleats 5 preferably are shaped to distribute stress on longitudinalmember 4, for example, by use of a curved portion between cleats. Thecleats 5 dissect through the soft tissue surrounding the rib and providepurchase into the inner part of the rib. Preferably, the cleats 5provide a distributed monocortical fixation of fractured bone whichassists to resist rotation of bone segments 3, 3′ relative to eachother. Cleats 5 preferably have a height range from 0.1 mm to 10 mm,more preferred is 1.5 mm. The cleats 5 need not be sharp. For example, arounded shape such as a cone may be used. Alternatively, the cleats 5may be shaped in the form of pins, spikes, pyramids, ridges, trapezoids,or any other suitable shape. The cleats 5 are preferably made of thesame material as the longitudinal member 4 described below.

The longitudinal member 4 may be constructed from an appropriatematerial such as, but not limited to, titanium, stainless steel,polymer, ceramic or a bio-resorbable material or combinations thereof.For the type of repair described herein, according to one non-limitingaspect of an illustrative embodiment, the longitudinal member 4 may beapproximately 4-12 mm in width, or more particularly 8 mm in width. Thelength of the longitudinal member 4 is as needed, but according to onenon-limiting aspect of the present invention may range from 30 mm to 300mm. The thickness of the longitudinal member 4 (not counting cleats 5)can be uniform or variable, such as providing greater thickness near themiddle of the longitudinal member to enhance stiffness or to tailor thestiffness to a specific level, such as to match the particular sectionof the rib bone. According to one non-limiting aspect of an illustrativeembodiment, the longitudinal member 4 thickness (not including thecleats) may range from 0.2 mm to 5 mm. The longitudinal member 4 may begenerally planar, or may instead be curved.

Turning to FIGS. 9 to 12, a pivoting locking post 20 is shown. Thepivoting locking post 20 is comprised of a lobed threaded shaft 24 withan insertion tab 22 and a head flange 26 with a center cannulation 28running along the center axis. Pivoting locking post 20 has an insertiontab 22 for inserting locking post 20 into the slots 14 in longitudinalmember 4. See FIGS. 6 to 8. Pivoting lock post 20 preferably furthercomprises a lobed threaded shaft 24 for holding the locking tab to anouter fastener (not shown) which is preferably a locking cap. In astandard threading system, the threads are put on round surfaces. Incontrast, in a lobed locking system, the threads are put on a lobedsurface where the peaks of the lobe act as cutting edges. The cuttingedges cut into the mated fastener to retard loosening of the twofasteners. The pivoting locking post 20 may be made of any suitablematerial including implantable-grade stainless steel or commerciallypure titanium or a titanium alloy.

Turning to FIGS. 13 to 16, a locking cap 30 is shown. Locking cap 30 hasa generally round top portion 31 containing multiple cut-outs 32 spacedaround the top portion 31. The rounded portion is attached to shaft 33.Shaft 33 may optionally have a cortex ridge 34 around shaft 33 forholding the locking cap in a bone segment. Rounded top portion 31 andshaft 33 have a threaded cannulation 35 running along the center axis.Rounded top portion 31 also contains removal slot 36 running acrossrounded top portion 31. The threaded cannulation 35 in locking cap 30holds locking cap 30 to an inner fastener (not shown) which ispreferably a pivoting locking post. The locking cap 30 may be made ofany suitable material including implantable-grade stainless steel orcommercially pure titanium or a titanium alloy.

As shown in FIG. 15, the generally round top portion 31 of locking cap30 may have an external drive feature 37 around its perimeter. In apreferred embodiment, there are between one to eight drive features. Ina more preferred embodiment, there are six drive features 37. In anotherpreferred embodiment, there are four drive features 37. In a preferredembodiment, drive feature 37 may be flat in shape.

When locking cap 30 is tightened by rotating (preferably using aself-retaining hex drive), the bottom of the rounded top portion oflocking cap 30 contacts the out cortex of the bone. The edges aroundcut-out 32 may be sharp so as to cut into the out cortex of the ribitself until the external drive on the lock cap sinks below the outercortex of the rib. As a result, the external flats are can no longer beengaged by, for example, the self-retaining hex drive.

Turning to FIGS. 17-22, a positioning forceps 40 used in an aspect of anillustrative embodiment is shown. Positioning forceps 40 contains guideholes 41 and 42 that are configured to receive a drill bit guide (notshown). Guide holes 41 and 42 are rotatable around pivots 43 and 44.Positioning forceps 40 also contains reference pivots 45 and 46.Reference pivots 45 and 46 are attached to forceps arms 47 and 48. Thepositioning forceps is most preferably made of stainless steel. In apreferred embodiment, forceps arms 47 and 48 are each made from a singlepiece of metal. The double-pivot double guide design of forceps 40provides stability and the ability of a drill sleeve (not shown) toremain centered over a bone segment (not shown). In a preferredembodiment, pivot 44 is load bearing.

Turning to FIG. 23, a drill bit guide 50 is shown. Drill bit guide 50has a shaft 51. Shaft 51 has threaded portion 52 to facilitate threadingthe shaft in guide hole 42 of positioning forceps 40. Shaft 51 also hasa serrated edge 53 on the side designed to contact a bone segment. Thispermits the drill bit 50 guide to cut through tissue surrounding thebone segment. Shaft 51 has a generally rounded knob 54 at its top. Knob54 has a flat portion 55 to prevent the knob from rolling, for example,on an operating tray. Shaft 51 also has longitudinal channel 56 alongits length configured to receive and guide a drill bit (not shown). Thedrill bit guide 50 is most preferably made of stainless steel.

Turning to FIG. 24, a drill bit 60 is shown. Drill bit 60 has a shaft 61and a point 62 at one end of shaft 61 of sufficient sharpness to drillinto bone. In a preferred embodiment, drill bit 60 has drill depthindicators 64, 66 and 68 to illustrate how deeply a bone has beendrilled. These depth indicators may be color coded. For example, depthindicator 64 could be blue-colored. Depth indicator 66 may bered-colored. Depth indicator 68 may be green colored. Drill depthindicators 64, 66 and 68 permit the selection of an outer fastener ofdifferent length depending on how deeply a bone has been drilled. Theouter fastener may also be color coded to correlate with the color ofthe drill depth indicator. The drill bit is most preferably made ofstainless steel.

FIG. 25 shows a drill bit guide 50 with drill bit 60 inserted therein.Point 62 protrudes from the bottom of drill guide 50 and drill depthindicators 64, 66 and 68 are also illustrated.

FIG. 26 shows a positioning forceps 40 with drill bit guide 50 insertedinto guide holes 41 and 42 and contacting bone segment 3 such that drillbit 60 (not shown) is generally centered over the width of bone segment3.

FIG. 27 shows an external drive tool. 70. External drive tool 70 has ahandle 72 at one end attached to a drive shaft 74 which is connected toa drive portion 76. As shown in FIG. 28 External drive tool 70 furthercontains a longitudinal channel 78 along its length which is configuredto receive a tether (not shown) used in an aspect of an illustrativeembodiment. The handle of the drive tool is most preferably made ofplastic, rubber, or silicon. The shaft and the drive portion are mostpreferably made of stainless steel. FIG. 29 shows a head-on view ofdrive portion 76.

Turning to FIGS. 30-53, a method of using the bone repair system torepair a patient's broken rib is illustrated. It should be understoodthat additional surgical steps may be performed and still be within thescope of the instant method.

FIG. 30 shows a patient 100 with three broken ribs R1, R2, and R3. Eachbroken rib has a first bone segment 102 and a second bone segment 104.FIG. 31 shows an incision 106 and ports 108 made in the patient's 100body in an area below the rib cage. Incision 106 and ports 108 may beused to insert surgical tools 110 and 112 including such tools as anendoscope. It should be understood that single or multiple incisionscould be used in the instant invention. Similarly, one or more ports 108could be used in the instant invention. Later figures show an incision106 for convenience of illustration.

FIG. 32 shows an incision template 114 placed over first bone segment102 and second bone segment 104. The template is an optional feature inan aspect of an illustrative embodiment to assist a surgeon in locatingpotential points of incision above rib bone segments 102 and 104. Theincision template 114 has a similar geometry to longitudinal member 4.The incision template is preferably made of stainless steel.

FIG. 33 shows positioning forceps 40 about to be inserted into incisions116 made using the incision template 114. Forceps 40 are preferablyinserted in closed position through the skin incision 116. Once the tipof the forceps 40 contacts the outer cortex of the rib, the forceps 40are opened, thereby allowing the tips of forceps 40 to go over each edgeof the rib.

In FIG. 34, positioning forceps 40 are engaged to bone segments 102 and104. Drill bit guide 50 is shown prior to insertion in guide holes 41and 42. In FIG. 35, positioning forceps 40 containing drill bit guide 50inserted into guide holes 41 and 42 prior to insertion of drill bit 60into drill bit guide 50. Drill bit 60 is used to drill holes 118 (notexplicitly shown) into bone segments 102 and 104.

In FIG. 36, drill bit 60 is inserted into drill bit guide 50. Drill bit60 has drill depth indicators 64, 66, and 68 are shown on drill bit 60.In a preferred embodiment, various sizes of locking caps 30 may beselected based on the depth of the hole drilled in a bone segmentaccording to depth indicators 64, 66, and 68.

In FIGS. 37 to 39, guide tubes 120 are inserted into drill bit guide 50and fed through the holes 118 in bone segments 102 and 104. In apreferred embodiment, one end of guide tubes 120 are pulled outside thepatient's body through incision 106 while the other end of the guidetubes 120 remains outside the patient's body above bone segments 102 and104. Guide tubes 120 are most preferably made of fluoropolymer plastic.The guide tubes preferably have an inner diameter in a range from 0.5 to10 mm. A preferred inner diameter is 1.6 mm. The guide tubes 120preferably also have a preferred outer diameter from 2 mm to 12 mm. Apreferred outer diameter is 3.2 mm. A preferred length is 1000 mm. Theuse of plastic guide tubes may allow the guide tubes to be directedthrough the body more easily and safely than bare tethers (which may bemade of metal). This may provide for smoother, less traumatic andefficient passage through the body.

FIG. 40 shows guide tubes 120 inserted into the patient's body afterremoval of the positioning forceps 40. FIG. 41 shows tethers 130 beinginserted into one end of the guide tubes 120. The tethers have beenpassed through pivoting locking posts 20. Pivoting locking posts 20 havebeen engaged in longitudinal member 4. In FIG. 42, are tethers 130 areshown passing through guide tubes 120 so that they are now outside eachend of guide tube 120. In FIG. 43, guide tubes 120 are removed from thebody while leaving tethers 130 in the body. Tethers 130 are mostpreferably made of stainless steel but could also be made of titanium orcobalt chrome. Tethers 130 preferably have as their dimensions 0.1 to 5mm in diameter (if they round), and most preferably 0.9 mm. The lengthof the tether is preferably 1000 mm. It should be understood that a“tether” may include a cable or wire or flexible rod including a rodmade of plastic or metal.

In FIG. 44, longitudinal member 4 is pulled into the body using tethers130. FIG. 45 shows a preferred embodiment of the arrangement of thelongitudinal member as it is pulled into the patient's body.Specifically, pivoting locking posts 20 are collapsed into longitudinalmember 4 so as to facilitate passage of the longitudinal member throughthe body to the bone segments to be repaired. Tether 130 passes througha longitudinal cavity in pivoting locking post 20. Ball 132 is attachedto tether 130 and pulls the pivoting locking post 20 and longitudinalmember 4 into the body. The locking posts can pivot between a collapsedposition and an extended position. Pivoting locking posts 20 are engagedinto longitudinal member 4 by inserting insertion tab 22 into slot 14.When pivoting locking posts 20 are moved away from slot 14, they areeffectively fixed into longitudinal member 4.

In FIG. 46, a preferred arrangement for the longitudinal member 4 andpivoting locking posts 20 is shown just prior to its insertion into theholes 118 in the bone segments. This embodiment permits the pivotinglocking posts 20 to pivot into a position generally perpendicular tolongitudinal member 4 just prior to insertion into holes in the bonesegment. FIG. 47 shows the assembly of FIG. 46 about to be inserted intothe holes 118 in bone segments 102 and 104

In FIG. 48, an external drive tool 70 has locking cap inserted in end76. Tether 130 is passed through this assembly to facilitate passage oflocking cap 30 to bone segments 102 and 104 where it will receivepivoting locking post 20. FIG. 49 further illustrates the process ofinserting locking cap 30 into external drive tool 70.

FIGS. 50A, 50B, and 50C show the process of tightening pivoting lockingpost 20 and locking cap 30. In FIG. 51, removal of external drive tool70 is shown along tethers 130. After external drive tool 70 is removedfrom the body, guide wires 130 are removed from the body.

FIG. 52 shows bone segments 102 and 104 joined using the bone repairsystem 1 in an aspect of an illustrative embodiment.

The bone repair system is removable in an aspect of an illustrativeembodiment. FIG. 53 provides a high level overview of the process.Removal driver 80 is inserted along tethers 130 to engage locking cap30. After engagement, locking cap 30 can be removed from pivotinglocking post 20 (not shown) and the bone repair system can be removedfrom the body in a conventional manner. Removal driver is mostpreferably made of the same materials external drive tool 70.

Any or all of the components described herein for completing the bonerepair in accordance with an aspect of the illustrative embodiments canbe assembled for ease of use as a surgical kit. A tray can be providedwhere the components can be conveniently and securely positioned forease of access and use during a surgery.

The system and method described herein allow for the rapid fixation ofbroken rib segments with less blood loss, and reduced post-operativepain and discomfort for the patient. Disruption of the surroundingmusculature, soft tissue, cartilage, periosteum and neural structurescould be significantly reduced when compared to conventional surgicaltechniques. This differs from some existing techniques which can bequite lengthy, utilize a wide exposure, use large muscle dissection andoften have a complicated recovery.

While exemplary embodiments are described above, it is not intended thatthese embodiments describe all possible forms of the invention. Rather,the words used in the specification are words of description rather thanlimitation, and it is understood that various changes may be madewithout departing from the spirit and scope of the invention.Additionally, the features of various implementing embodiments may becombined to form further embodiments of the invention.

What is claimed is:
 1. A system for the percutaneous repair of a firstbone segment and a second bone segment of a fractured bone having adrill hole in each bone segment in a patient comprising: a longitudinalmember configured to contact the first bone segment and the second bonesegment and having at least one opening and cleats on a bottom side ofthe longitudinal member adapted to contact the first bone segment andthe second bone segment; a first fastener assembly configured to bedisposed through the at least one opening of the longitudinal member tohold the longitudinal member in place through the opening and the holein the first bone segment, the first fastener assembly including a firstinner fastener and a first outer fastener, wherein the first innerfastener is a pivoting locking post having a shaft and a head flangeintegrally formed with the shaft, the head flange having an insertiontab; and a second fastener assembly configured to be disposed throughthe at least one opening of the longitudinal member to hold thelongitudinal member in place through the opening and the hole in thesecond bone segment, the second fastener assembly including a secondinner fastener and a second outer fastener, wherein the second innerfastener is a pivoting locking post having a shaft and a head flangeintegrally formed with the shaft, the head flange having an insertiontab; wherein the longitudinal member has slots in each opening adaptedto receive a respective insertion tab to engage the pivoting lockingposts into the longitudinal member, and wherein each pivoting lockingpost can pivot between a collapsed position with its head flange rotatedbelow the bottom side of the longitudinal member and an extendedposition such that its shaft moves while its head flange remains fixedin position along the longitudinal member.
 2. The system of claim 1,wherein the longitudinal member contains a first opening and a secondopening and the first fastener assembly is configured to be disposedthrough the first opening of the longitudinal member to hold thelongitudinal member in place through the first opening and the hole inthe first bone segment; and wherein the second fastener assembly isconfigured to be disposed through the second opening of the longitudinalmember to hold the longitudinal member in place through the secondopening and the hole in the second bone segment.
 3. The system of claim1, wherein the first outer fastener is a locking cap and the secondouter fastener is a locking cap.
 4. The system of claim 3, wherein thefirst and second outer fasteners are shaped so as to be turnable by anexternal drive.
 5. The system of claim 3, wherein either the lockingcaps or the pivoting locking posts have lobed locking threads.
 6. Thesystem of claim 3, wherein the locking caps have cutouts spaced aroundthe cap so as to grip and dig into the outer cortex of a bone segmentwhen contacted against a bone segment and wherein the cutouts are ofsufficient depth to restrain the caps from being overtightened.
 7. Thesystem of claim 3, wherein a portion of each of the locking caps isrounded in shape and has at least one external drive feature.
 8. A kitfor surgical repair of a fractured bone involving a first bone segmentand a second bone segment, comprising: a first tether and a secondtether each having a proximal end and a distal end configured to beinserted into a first guide tube and a second guide tube respectively; alongitudinal member having at least one opening configured to receive afirst fastener assembly and a second fastener assembly wherein thelongitudinal member is configured to be in contact with the first andsecond bone segments and has cleats on a bottom side of the longitudinalmember configured to be in contact with the first and second bonesegments; a first fastener assembly having a longitudinal channelconfigured for passing the first tether therethrough and furtherconfigured to hold the longitudinal member against the first bonesegment, the first fastener assembly including a first inner fastenerand a first outer fastener, wherein the first inner fastener is apivoting locking post having a shaft and a head flange integrally formedwith the shaft, the head flange having an insertion tab; and a secondfastener assembly having a longitudinal channel configured for passingthe second tether therethrough and further configured to hold thelongitudinal member against the second bone segment, the second fastenerassembly including a second inner fastener and a second outer fastener,wherein the second inner fastener is a pivoting locking post having ashaft and a head flange integrally formed with the shaft, the headflange having an insertion tab; wherein the longitudinal member hasslots in each opening adapted to receive a respective insertion tab toengage the pivoting locking posts into the longitudinal member, andwherein each pivoting locking post can pivot between a collapsedposition with its head flange rotated below the bottom side of thelongitudinal member and an extended position such that its shaft moveswhile its head flange remains fixed in position along the longitudinalmember.
 9. The kit of claim 8, wherein the longitudinal member has afirst opening configured to receive the first fastener assembly and asecond opening configured to receive the second fastener assembly. 10.The kit of claim 8, further comprising a first guide tube and a secondguide tube.
 11. The kit of claim 8, further comprising an incisiontemplate.
 12. The kit of claim 8, further comprising a positioningforceps configured to engage a bone segment and a drill guide configuredto be received through the positioning forceps for facilitating drillinga hole in a bone segment.
 13. The kit of claim 8, further comprising adrive tool having a longitudinal channel configured to pass a tethertherethrough.
 14. The kit of claim 8, wherein the kit contains aplurality of outer fasteners configured to fit in bone segments ofvarious thicknesses.
 15. The kit of claim 8, wherein the first outerfastener is a locking cap and the second outer fastener is a lockingcap.
 16. The kit of claim 8, further comprising a removal driver. 17.The kit of claim 8, further comprising packaging containing the kitcomponents.
 18. The kit of claim 8, further comprising packagingcontaining the longitudinal member, the first tether, the second tether,the first fastener assembly, and the second fastener assembly andwherein the longitudinal member, the first tether, the second tether,the first fastener assembly and the second fastener assembly have beensterilized.